Reported Apr 8, 2020 · Ongoing

Philips V60 Ventilators with Power Management PCBA part number 1055906

Respironics California, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Respironics California, LLC · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517

Is this the product you have?

  • Philips V60 Ventilators with Power Management PCBA part number 1055906
Lot codes and dates
  • Serial Numbers
    • 100002908 to 100027093
    • 100027096 to 100085389
    • 100085399 to 100109746
    • 100109868 to 201003390
    • 201003392 to 201010952
Amount recalled
23581

Where it was sold

Why it was recalled

Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:16 PM UTC

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